OneTouch Ultra® Plus Test Strips

When used in conjunction with a OneTouch Ultra® Plus blood glucose monitoring system (hereinafter referred to as a glucose meter), the OneTouch Ultra® Plus Flex™; test strips are designed to quantify glucose (sugar) in fresh, whole capillary blood drawn from a finger tip. For information on blood samples, refer to the User Guide that came with the glucose meter. The OneTouch Ultra® Plus blood glucose monitoring systems are designed for self-monitoring and operate outside the human body (designed for in vitro diagnostics). They can be used at home by people with diabetes and by medical professionals to examine patients in the clinic as a means of monitoring the effectiveness of diabetes control.

Principle of testing

The OneTouch Ultra® Plus series glucose meters are calibrated to plasma glucose levels to facilitate comparison of results with laboratory methods. The glucose in the blood sample is mixed with special reagents in the test strip to produce a small electric current. The strength of this current varies in proportion to the amount of glucose in the blood sample. The OneTouch Ultra® Plus series glucose meters measure this current, calculate the blood glucose level, and display the test result on the screen.

For detailed information on how to use the glucose meter and other important technical information, refer to the user manual that came with the glucose meter. IF YOU HAVE ANY QUESTIONS ABOUT THE USE OF ANY LIFESCAN PRODUCTS, please call the Lifescan Customer Care at 0 800 500 353 (free of charge in Ukraine), Mon-Fri, 09:00-18:00.

• Store the test strip vial in a dry place at a temperature (t) between 5 °C and 30 °C and a relative humidity of up to 65%. Do not store the vial in the refrigerator. Protect from direct sunlight and heat. Exposure to temperatures (t) and/or humidity levels outside the recommended storage limits may cause inaccurate test results. 
• Tests using test strips should be performed at a temperature (t) between 6 °C and 44 °C and a relative humidity between 10% and 90%. 
• The expiration date is printed on the vial. 
• The disposal date of the vial contents is the date of first opening of the vial with test strips plus 6 months. After opening a new vial, write the disposal date on the label. 
• Do not use test strips after the expiration date or disposal date (whichever comes first). 
• Store test strips only in the original vial. To avoid damage or contamination, do not transfer test strips to any other packaging. 
• Only open the vial when you want to take a test strip for further use. 
• Immediately close the vial tightly with the cap after removing the test strip. Remove the test strip from the vial immediately before use. 
• Do not use test strips if the vial is damaged or has been left open. 
• Avoid contact of test strips with dirt, food, or liquids. You can touch any part of the test strip surface with clean, dry hands. 
• Do not bend, cut, or deform the test strips. 
• Test strips are intended for single use only. 
• Never reuse a test strip that has already been applied with blood or control solution. 
• Before testing, make sure that the meter and test strips are at approximately the same temperature (t). 
• Only OneTouch Ultra™ Plus control solution or blood sample may be applied to the test strip. 
• Do not return the used test strip to the vial after testing.
• In your region, used test strips may be considered biohazardous waste. When disposing of them, follow the advice of medical professionals and local regulations.

WARNING! Keep the test strip vial out of the reach of children. Swallowing a test strip may cause airway obstruction or suffocation. Do not swallow test strips. The test strip vial may contain a desiccant that is harmful if inhaled or swallowed and may cause skin or eye irritation. Do not swallow any components of the kit.

IMPORTANT! Before use, read the test strip instructions and the user manual for the glucose meter supplied with your system. The user manual contains complete instructions for measuring blood glucose levels and performing a control solution test. Do not use new test strips if the vial is open or damaged in any way. This may result in error messages or inaccurate blood glucose readings. Contact Customer Service immediately if you have any questions about the test strips or test results.

• If your blood glucose results do not match your symptoms, and you have followed all the instructions in the user manual for your glucose meter, contact your doctor.
• Never ignore your symptoms or make significant changes to your diabetes management program without consulting your healthcare provider.

Restrictions on the procedure

For accurate results, use OneTouch Ultra® Plus test strips, observing the following conditions:
The OneTouch Ultra® Plus series of blood glucose meters is intended for use by a single patient; these devices should not be shared with other people. 
The OneTouch Ultra® Plus series of blood glucose meters should not be used for the diagnosis or screening of diabetes mellitus, or for determining blood glucose levels in newborns. 
The OneTouch Ultra® Plus series of blood glucose meters should not be used in critically ill patients, patients in shock, patients in severe dehydration, or patients in a hyperosmolar state (with or without ketosis). 
Do not use serum or plasma. 
Hematocrit is the percentage of red blood cells in the blood. Too high or too low hematocrit values can affect test results. A hematocrit level below 20% may cause false high readings. A hematocrit level above 60% may cause false low readings. Consult your healthcare professional if you do not know your hematocrit level. 
The OneTouch Ultra® Plus series of blood glucose meters is not recommended for testing blood samples obtained from alternative sites (AST). 
OneTouch Ultra® Plus test strips should not be used at altitudes above 3048 m (10,000 ft) above sea level, as this may adversely affect test results. 
Other substances that may affect glucose determination: Uric acid and other reducing substances (when present in the blood at high normal or maximum therapeutic concentrations) do not significantly affect test results. However, pathologically high concentrations of these substances in the blood may cause low results.

• The OneTouch Ultra® Plus series of blood glucose meters should not be used in patients who have undergone a D-xylose absorption test within the previous 24 hours, as this may cause false high results.
• Do not use OneTouch Ultra® Plus blood glucose meters if it is known or suspected that PAM (Pralidoxime) is present in the patient's whole blood sample.

1 pack — 1 vial containing 50 test strips.

Manufactured at the factory:

LifeScan Scotland Limited, United Kingdom.

Service support:

If you have any questions about OneTouch products, please contact the Lifescan Customer Care at: 0 800 500 353 (free of charge in Ukraine), Monday-Friday, 09:00-18:00.